Recanalization Therapies in Acute Ischemic Stroke Patients: Impact of Prior Treatment with Novel Oral Anticoagulants on Bleeding Complications and Outcome - A Pilot Study
Background—We explored the safety of intravenous thrombolysis (IVT) or intra-arterial treatment (IAT) in ischemic stroke patients on novel oral anticoagulants (NOAC, last intake <48hours) compared to patients (i) taking vitamin K-antagonists (VKA) or (ii) without prior anticoagulation (no-OAC).
Methods and Results—Multicenter cohort pilot study. Primary outcome measures were (i) occurrence of ICH in three categories - any intracranial hemorrhage (ICHany), symptomatic ICH according to the criteria of the ECASS-II (sICHECASS-II) and the NINDS thrombolysis trial (sICHNINDS); and (ii) death (at 3 months). Cohorts were compared by using propensity score matching. Our NOAC cohort comprised 78 patients treated with IVT/IAT and the comparison groups of 441 VKA-patients and 8938 no-OAC patients. The median time from last NOAC intake to IVT/IAT was 13 hours (interquartile range [IQR] 8-22h). In VKA-patients, median pre-IVT/IAT INR was 1.3 (IQR 1.1-1.6). ICHany was observed in 18.4% NOAC patients versus 26.8% in VKA patients and 17.4% in no-OAC patients. sICHECASS-II and sICHNINDS occurred in 2.6%/3.9 % NOAC patients, compared to 6.5%/9.3% of VKA patients and 5.0%/7.2% of no-OAC patients, respectively. At 3 months, 23.0% of NOAC patients compared to 26.9% of VKA patients and 13.9% of no-OAC patients had died. Propensity score matching revealed no statistical significant differences.
Conclusions—IVT/IAT in selected patients with ischemic stroke under NOAC treatment has a safety profile similar to both, IVT/IAT in patients on subtherapeutic VKA-treatment or in those without prior anticoagulation. However, further prospective studies are needed, including the impact of specific coagulation tests.
- Novel oral anticoagulants
- direct oral anticoagulants
- intravenous thrombolysis
- intra-arterial treatment
- Non-Vitamin-K anticoagulants
- Received March 4, 2015.
- Revision received July 20, 2015.
- Accepted July 23, 2015.